Neoplasms

All Conditions

Infections

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Virus Diseases

Papilloma

Oropharyngeal Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2.

The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2.

Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions

SABR boost and de-escalated chemoradiation

Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions

Standard chemoradiation

Diane Trudel

Mom Phat

Houda Bahig

Phuc-Félix Nguyen-Tan

Houda Bahig, MD PhD

Phuc-Felix Nguyen-Tan, MD

David Palma, MD PhD

Jack Phan, MD PhD

Khalil Sultanem, MD

This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.

Concurrent platinum-based chemoradiation remains the standard of care in locally advanced head and neck cancer. The current standard radiation regimen consists in a 7-week course of conventionally fractionated radiotherapy to the gross tumor volume (GTV), along with bilateral prophylactic neck irradiation to an elective dose of \~ 50 Gy in 2 Gy per fraction. In addition to being cumbersome, the current protracted daily radiation course is associated with high rates of acute and late toxicities and significant deterioration of patients' quality of life. In the light of the remarkably improved prognosis of the distinct subgroup of HPV-OPC, there is growing interest for treatment de-intensification strategies in contemporaneous OPC cohorts.

Stereotactic ablative radiotherapy (SABR) allows for ultra-precise delivery of ablative radiation dose over a small number of fractions, by combining sharp dose gradients with use of optimal image guidance. The increased conformity and reduced margins used in SABR can substantially reduce the dose to surrounding organs at risk and could therefore reduce toxicity. In addition, previous work has shown that an elective dose of 40 Gy in 2 Gy per fraction, in conjunction with chemotherapy, is sufficient for microscopic sterilisation of cancer cells and can translate into a reduction of toxicities.

The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 fractions followed by de-esclalated chemoradiation (40 Gy in 20 fractions and concurrent 2 cycles of Cisplatin 100mg/m2) in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation (70 Gy in 33 fractions with 2-3 cycles of Cisplatin 100mg/m2).

This is an open label randomized phase II trial with 2 planned interim safety (toxicity) analysis and 1 futility (locoregional control) analysis with go/no go decision to pursue the study based on probabilities of toxicities and LRC (Bayesian adaptive design). Patients will be randomized using a 1:1 ratio between the standard and the experimental arm and will be stratified by tumor stage. At the significance level of 0.2 and assuming the LRC rate of 90% for both experimental and control arms, 80% for the non-inferiority test with the margin of 10%, and 6% attrition rate, a total of 106 patients will be enrolled.

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase II Trial

Patient alive with locoregional control at 2 years after the end of chemoradiation

Patient-reported head and neck symptom burden as measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module. The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.

Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.

Time from first day of treatment start to first day of return to work.

M.D. Anderson Cancer Center

Lawson Health Research Institute

Jewish General Hospital

Centre hospitalier de l'Université de Montréal (CHUM)

Radiation Oncologist

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Open/minimaly invasive pelvic and para-aortic lymph node dissection

Lymph node dissection

1. A point/HCR-CTV D90 ≥80Gy（+20%）
2. Extended-field EBRT: image-positive common iliac lymph nodes with short diameter ≥10mm and/or image-positive para-aortic lymph node
3. Target doses for the image-positive nodes can range from 55 to 60Gy
4. Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week)
5. CCRT will be completed in 56 days
6. After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 \< 96Gy) will be performed.

1. A point/HCR-CTV D90 ≥80Gy（+20%）
2. Extended-field EBRT: Pathlogical positive para-aortic lymph node
3. Target doese for pelvic and/or abdomal lymph nodes is usually 45Gy. After operation, the residual lymph node need to be labeled and the target doses for it ranges from 55-60Gy.
4. Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week)
5. CCRT will be completed in 56 days
6. After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 \< 96Gy) will be performed.

Chemoradiation

Dongling Zou, M.D.

Ying Tang, M.D.

Misi He, M.M.

This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and/or OS with lymph node dissection before CCRT when compared to CCRT.

All eligible patients will be equally randomized between the 2 following treatment groups (stratified factors: whether para-aortic lymph nodes were image-positive):

Standard treatment group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy).

Experimental group: open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be performed postoperatively within 28 days.)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer	NCT04178174	Head and Neck C... Oropharynx Canc... Human Papilloma...	SABR boost and ... Standard chemor...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)	NCT04555226	Cervical Cancer	Lymph node diss... Standard chemor... Chemoradiation	18 Years - 70 Years	Chongqing University Cancer Hospital

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