Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Disease Attributes

Pencil beam proton radiotherapy

Camilla Kronborg, MD, PhD

Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.

Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy

Neo-adjuvant treatment: Rate of pathological complete resection (R0)

Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.

Local re-recurrence determined by imaging 6, 12 and 24 month post treatment

Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course

Overall survival defined as time from first day of treatment to death from any cause

Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic

Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic

University of Aarhus

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Capecitabine

Levoleucovorin

Antimetabolites

Folinic Acid

Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy

Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)

Adjuvant chemotherapy: CAPOX (capecitabine+oxaliplatin) or mFOLFOX6 (5-fluorouracil+l-leucovorin+oxaliplatin) or capecitabine or 5-fluorouracil (FU) +l-leucovorin (LV)

CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)

mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.

Capecitabine: 2000 mg/m2/day, twice daily, days 1-14

5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

Surgery plus Adjuvant chemotherapy

Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV

CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)

mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.

Capecitabine: 2000 mg/m2/day, twice daily, days 1-14

5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV

CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)

mFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.

Capecitabine: 2000 mg/m2/day, twice daily, days 1-14

5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

Chemotherapy

Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy

Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)

Preoperative radiotherapy

Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B.

Appropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection

Procedure

Yuichiro Tsukada, MD,PhD

Masaaki Ito, MD, PhD

Nobuhiro Takiguchi

Kazuhiro Yoshida

Shigeki Yamaguchi

Mitsugu Sekimoto

Mamoru Shimomura

Masazumi Okajima

Yoshitsugu Tajima

Hiroyuki Bando

Masaaki Ito

Hideyuki Ishida

Ryo Inada

Hideo Baba

Kazuyuki Kawamoto

Yoshito Akagi

Takaya Kobatake

Tadahiko Masaki

Koki Otsuka

Keisuke Uehara

Yasumasa Takii

Naohiro Tomita

Yoshihiro Akazai

Takeshi Kato

Kiyoshi Maeda

Yusuke Nishizawa

Hideki Yamagami

Kou Miura

Akio Shiomi

Tsunekazu Mizushima

Shu Okamura

Junji Okuda

Hideki Ueno

Yukihide Kanemitsu

Yoshihisa Saida

Kimihiko Funahashi

Yusuke Kinugasa

Akihiko Tsuchida

Keiichi Takahashi

Shin Fujita

Toshihiko Sato

Manabu Shiozawa

Tadao Fukushima

Jun Watanabe

Masafumi Inomata

Yuichi Takayama

Hitoshi Ojima

JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.

In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions), and quality of life after surgery.

Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)

the period from registration in the trial to either the first event of local relapse or death from any cause and censored at the last date of contact for a living patient

s the time from registration to death from any cause and censored at the last date of contact for a living patient

the time from registration to either the first incidence of relapse or death from any cause and censored at the last date of contact for a living patient

Proportion of patients with pathological R0 resection

Pathological complete response rate (arm B)

Proportion of patients who completed the protocol treatment

Incidence of adverse events (adverse reactions)

QOL after surgery based on the Trial Outcome Index-Physical/Functional/Colorectal (TOI-PFC) \[0(better)-84(worse)\]

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy	NCT04695782	Rectal Cancer R...	Pencil beam pro...	18 Years -	University of Aarhus
Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer	NCT04288999	Rectal Cancer R...	Chemotherapy Preoperative ra... Procedure	20 Years - 80 Years	National Cancer Center Hospital East

Spots Global Cancer Trial Database for rectal cancer recurrent