A phase I/II trial of three-dimensionally planned concurrent boost radiotherapy and protracted venous infusion of 5-FU chemotherapy for locally advanced rectal carcinoma

Purpose To describe a new beam arrangement for preoperative concurrent boost radiotherapy in locally advanced rectal carcinoma. Material and methods Three different volumes, ie posterior pelvis, total mesorectal space, and gross tumor volume plus 2 cm, are selected to receive radiation doses of 47 Gy, 51 Gy, and 54 Gy, respectively, in 24 fractions. There are two prerequisites for the use of such a radiotherapy schedule: complete displacement of the small bowel outside the boost volume, and horizontal positioning of the rectal long axis. Both conditions can be attained by patient positioning on a new device, the “Up-Down Table” (UDT). The dose gradient between the three volumes is realized with two daily arc rotation fields with an isocenter that is different from the three additional multileaf collimator pelvic fields (postero-anterior + 2 laterolateral). Results The treatment data are reported according to the ICRU 62 criteria. A comparison was made between concurrent arc rotation and concomitant static boost techniques. Conclusion The new beam arrangement, with the use of the UDT, allows to administer different radiation doses to three volumes with different tumor cell density in order to obtain the same probability of local response in all target volumes without increasing the toxicity.

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A phase I/II trial investigating weekly docetaxel and carboplatin (DC) given neoadjuvantly and then concurrently with concomitant boost radiotherapy (CB-XRT) for locally advanced squamous cell carcinoma of the head and neck

Journal of Clinical Oncology ◽

10.1200/jco.2004.22.14_suppl.5543 ◽

2004 ◽

Vol 22 (14_suppl) ◽

pp. 5543-5543

Author(s):

D. L. Schwartz ◽

B. Yueh ◽

R. B. Montgomery ◽

M. Donahue ◽

R. Canby ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Phase I ◽

Cell Carcinoma ◽

Head And Neck ◽

Squamous Cell ◽

Locally Advanced ◽

Advanced Squamous Cell Carcinoma ◽

Weekly Docetaxel ◽

Concomitant Boost ◽

Boost Radiotherapy

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Eastern Cooperative Oncology Group Phase I Trial of Protracted Venous Infusion Fluorouracil Plus Weekly Gemcitabine With Concurrent Radiation Therapy in Patients With Locally Advanced Pancreas Cancer: A Regimen With Unexpected Early Toxicity

Journal of Clinical Oncology ◽

10.1200/jco.2000.18.19.3384 ◽

2000 ◽

Vol 18 (19) ◽

pp. 3384-3389 ◽

Cited By ~ 91

Author(s):

Mark S. Talamonti ◽

Paul J. Catalano ◽

David J. Vaughn ◽

Richard Whittington ◽

R. Daniel Beauchamp ◽

...

Keyword(s):

Radiation Therapy ◽

Phase I ◽

Dose Level ◽

Phase I Trial ◽

Pancreas Cancer ◽

Locally Advanced ◽

Stevens Johnson Syndrome ◽

Severe Bleeding ◽

Severe Thrombocytopenia ◽

Venous Infusion

PURPOSE: We performed a phase I trial of protracted venous infusion (PVI) fluorouracil (5-FU) plus weekly gemcitabine with concurrent radiation therapy in patients with locally advanced pancreas cancer to determine the maximum-tolerated dose of gemcitabine that could be safely administered. We also sought to identify the toxicities associated with this treatment protocol. PATIENTS AND METHODS: Seven patients with locally advanced pancreas cancer were treated with planned doses of radiation (59.4 Gy) and PVI of 5-FU (200 mg/m2/d) with gemcitabine doses of 50 to 100 mg/m2/wk. RESULTS: Two of three patients at the 100-mg/m2/wk dose level experienced dose-limiting toxicity (DLT), as did three of four at the 50-mg/m2/wk dose level. One patient experienced a mucocutaneous reaction described as a Stevens-Johnson syndrome that was attributed to chemotherapy. Three patients developed gastric or duodenal ulcers with severe bleeding requiring transfusion. One patient developed severe thrombocytopenia lasting longer than 4 weeks. Three of the five episodes of DLT developed at radiation doses ≤ 36 Gy. CONCLUSION: Based on this experience, we cannot recommend further investigation of regimens incorporating gemcitabine into regimens of radiation with PVI 5-FU. The mechanism of this synergistic toxicity remains to be determined.

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A phase I/II study of S-1 plus oxaliplatin combined with radiation (SOX/RT) for preoperative locally advanced rectal carcinoma (JACCRO CC-04: SHOGUN trial).

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.602 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 602-602

Author(s):

Toshiaki Watanabe ◽

Satoshi Matsusaka ◽

Soichiro Ishihara ◽

Keisaku Kondo ◽

Hisanaga Horie ◽

...

Keyword(s):

Phase I ◽

Rectal Carcinoma ◽

Phase Ii ◽

Primary Endpoint ◽

Locally Advanced ◽

Pathologic Complete Response ◽

Dose Intensity ◽

Maximum Tolerated Dose ◽

Sphincter Preservation ◽

Level 3

602 Background: Previous western trials of preoperative chemoradiation (CRT) in patients with locally advanced rectal carcinoma (LARC) have been shown to increase the chance of sphincter preservation and local control, and has become the standard of care in western countries. In Japan, preoperative CRT has not been utilized in LARC and its value is unconfirmed. Thus, we conducted a phase I/II study of preoperative CRT with S-1, which is widely used oral fluoropyrimidine in Japan to treat gastrointestinal cancer, plus oxaliplatin in patients with LARC. Methods: Patients with histopathologically confirmed LARC (cT3-T4, any N) were eligible. A total radiation dose of 50.4 Gy was delivered in 28 fractions over 5 weeks, and S-1 was orally administered 40mg/m2 twice a day for 5 days a week at 1st, 2nd, 4th and 5th week. Oxaliplatin was administered at a dose of 40 mg/m2 (level 1), 50 mg/m2 (level 2) or 60 mg/m2(level 3) on day 1, 8, 22 and 29. Surgery was performed within 6-10 weeks after CRT. The primary endpoint of phase I part was to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of oxaliplatin. Primary endpoint of phase II was evaluated pathologic complete response (pCR) rate at RD. Results: 13 patients were enrolled in the phase I part, 2 dose-limiting toxicities (DLTs, skipping oxaliplatin due to the grade 2 neutropenia) occurred in the dose level 3, and the MTD was not reached. In phase II, 45 patients were treated at the RD of oxaliplatin (60 mg/m2) and 44 patients (97.8%) underwent surgery. A pCR was observed in 12 patients (27.3%). The relative dose intensity of radiation, S-1, oxaliplatin was 98.4%, 94.0%, and 94.3%, respectively. The incidence of grade 3-4 diarrhea and neutropenia was 8.9% and 2.2%, respectively. Postoperative complications of any grade occurred in 27.3% of patients. Conclusions: Preoperative CRT with S-1 plus oxaliplatin showed promising results in pathological responses and favorable toxicities profiles. Clinical trial information: NCT01227239.

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