A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOsaka University

About this trial

A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. The patient has been fully informed of the contents of the study and has given written consent.

Neutrophil count: greater than or equal to 1,500/mm3

Platelet count: >= 10.0 x 104 /mm3

Hemoglobin concentration: >=9.0 g/dL

Disqualifiers

1. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy

extensive surgery (excluding CV port placement) within 4 weeks

Any anticancer therapy within 4 weeks

Radiation within 4 weeks 2. concomitant or pre-existing severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.) 3. patients who have had a colonic stent implanted 4. patients with serious comorbidities (heart failure, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, bowel obstruction, poorly controlled diabetes, etc.) 5. patients with active multiple overlapping cancers (synchronous multiple overlapping cancers or iatrogenic multiple overlapping cancers with a disease-free period of 5 years or less). However, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is considered curable by local treatment is not considered active multiple overlapping carcinoma.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Radiation

    Radiation

    Neoadjuvant radiation therapy : 5Gyx5

  • Chemotherapy

    Drug

    CAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles

  • Surgery

    Procedure/Surgery

    Operation: Total methorectum excision wiht radical lymph node dissection

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: TNTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR)

pCR is evaluated by using the grading scale according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma

Time frame
through study completion, an average of 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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