Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Etoposide

Gemcitabine

Vinorelbine

Pembrolizumab

Docetaxel

Albumin-Bound Paclitaxel

Cisplatin

Immunomodulating Agents

Etoposide phosphate

Nedaplatin

The patient will receive carbon ion radiotherapy with 70Gy per 20 fractions. Patients with genetic mutations (including but not limited to EGFR, ALK, etc.) should receive targeted therapy as their systemic therapy. For patients who are not suitable for targeted therapy, we recommend single regimen chemotherapy in sequence with radiotherapy. The drugs include etoposide, platinum (carboplatin, cisplatin, nedaplatin or loplatin), vinorelbine, paclitaxel (including liposome paclitaxel and albumin paclitaxel), docetaxel, pemetrexel, gemcitabine, etc. If there is no contraindication to PD-1/PD-L1 immunotherapy, it can be combined with immunotherapy, such as Pembrolizumab. For patients who cannot tolerate chemotherapy, PD-1/PD-L1 immunotherapy is recommended. The progression-free survival rate, toxicity, local control rate, cause-specific survival rate and overall survival rate were observed with regular follow-up after treatment.

carbon ion radiotherapy

targeted therapy

single regimen chemotherapy in sequence with radiotherapy

Jing Li

Kun Liu

Jian Chen, MD

Jingfang Mao, PHD

Kai-liang Wu, PHD

To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy.

Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients

A Prospective Phase II Clinical Study of Carbon Ion Radiotherapy for Locally Advanced Non-small Cell Lung Cancer in the Older Adult

Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.

Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.

Local control rate was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up

Cause-specific survival rate was defined from the start of carbon ion radiotherapy till the date of death caused by non-small cell lung cancer treated in this study or the last follow-up

Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up.

Jian Chen

Clinical Professor

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Oxaliplatin

Fluorouracil

Capecitabine

* SCRT (5 fractions of 5 Gy)
* Surgery (according to the principle of TME) or watch \& wait
* Optional adjuvant chemotherapy

Rapido regimen:

* SCRT (5 fractions of 5 Gy)
* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)
* Surgery (according to the principle of TME) or "watch \& wait"

Or

Rapido light regimen:

* SCRT
* Up to 12 weeks of oxaliplatin based chemotherapy
* Surgery or "watch \& wait"

Or

OPRA with induction chemotherapy (INCT-CRT) regimen:

* Up to 16 weeks of oxaliplatin-based chemotherapy
* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion ﬂuorouracil or capecitabine)
* Surgery or "watch \& wait"

Or

OPRA with consolidation chemotherapy (CRT-CNCT) regimen:

* CRT
* Up to 16 weeks of oxaliplatin-based chemotherapy
* Surgery or "watch \& wait"

Patients will receive 5 daily fractions of radiotherapy. Each fraction will consist of 5 Gy for a total dose of 25 Gy.

Short course radiotherapy

The choice of the adjuvant chemotherapy is to the investigator's discretion.

Adjuvant chemotherapy (optional)

Surgery must be performed according to the principles of total mesorectal excision. A "watch \& wait" approach is allowed for those subjects who have clinical complete response according to the local assessment.

Total mesorectal excision

The choice of the TNT is left to the investigator's discretion.

If RAPIDO:

* SCRT (5 fractions of 5 Gy), followed by
* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)

If RAPIDO light:

* SCRT (5 fractions of 5 Gy), followed by
* Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)

If OPRA with induction chemotherapy:

* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by
* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion ﬂuorouracil or capecitabine)

If OPRA with consolidation chemotherapy:

* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion ﬂuorouracil or capecitabine) followed by
* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX)

Total neoadjuvant therapy

Tabatha Delsaute

Laurène Huberty

Timon Vandamme, MD

Rita Institut Jules Bordet, MD

Rita Saude Conde, MD

Francesco Puleo, MD

Karen Geboes, MD

Willem Lybaert, MD

Alexandre Dermine, MD

Sandra Mupingu, MD

Isabelle SINAPI, MD

Laurence FAUGERAS, MD

Ines Joye, MD

Sylvie Lecomte, MD

Amelie Deleporte, MD

Yeter Gokburun, MD

Francesco Sclafani

The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.

The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.

Subjects meeting all eligibility criteria will be randomised in a 1:1 ratio to either the SCRT arm or the TNT arm (The study design is shown in figure 3.1 and 3.2).

SCRT arm:

The SCRT arm consists of:

* SCRT (5 fractions of 5 Gy), followed by
* Surgery (according to the principles of TME) or watch \& wait, followed by
* Optional adjuvant chemotherapy

TNT arm Different treatment regimens can be used in the TNT arm including Rapido, Rapido light, OPRA INCT-CRT or OPRA CRT-CNCT. The regimen to use will be decided by the investigator and will need to be declared before randomisation. No switch between regimens is allowed during the study treatment period.

The Rapido regimen consists of:

* SCRT (5 fractions of 5 Gy), followed by
* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by
* Surgery (according to the principle of TME) or "watch \& wait".

The Rapido light regimen consists of:

* SCRT (5 fractions of 5 Gy), followed by
* Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by
* Surgery (according to the principle of TME) or "watch \& wait".

The OPRA with induction chemotherapy (INCT-CRT) regimen, consists of:

* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by
* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion ﬂuorouracil or capecitabine) followed by
* Surgery (according to the principle of TME) or "watch \& wait"

The OPRA with consolidation chemotherapy (CRT-CNCT) regimen consists of:

* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion ﬂuorouracil or capecitabine) followed by
* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by
* Surgery (according to the principle of TME) or "watch \& wait".

Efficacy and Safety of SCRT Versus TNT in Older Patients With Locally Advanced Rectal Cancer

Efficacy and Safety of Short-course Radiotherapy (SCRT) Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial

Overall survival (OS) will be calculated from randomisation to death from any cause.

Progression-free survival (PFS) will be calculated from randomisation to any of the following events: unresectable tumour due to local tumour progression, R2 resection of the primary tumour, loco-regional recurrence after an R0/R1 resection, distant metastases, or death from any cause.

Any grade peripheral sensory neuropathy as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.

Grade ≥3 toxicities during treatment (i.e., from the 1st day of treatment until the EOT visit) as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients	NCT06311981	Non-small Cell ... Older People Carbon Ion Radi... Radiotherapy Si...	carbon ion radi... targeted therap... single regimen ...	75 Years -	Shanghai Proton and Heavy Ion Center
Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients	NCT06311981	Non-small Cell ... Older People Carbon Ion Radi... Radiotherapy Si...	carbon ion radi... targeted therap... single regimen ...	75 Years -	Shanghai Proton and Heavy Ion Center
Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients	NCT06311981	Non-small Cell ... Older People Carbon Ion Radi... Radiotherapy Si...	carbon ion radi... targeted therap... single regimen ...	75 Years -	Shanghai Proton and Heavy Ion Center
Efficacy and Safety of SCRT Versus TNT in Older Patients With Locally Advanced Rectal Cancer	NCT06052332	Locally Advance... Older People	Short course ra... Adjuvant chemot... Total mesorecta... Total neoadjuva...	70 Years -	Jules Bordet Institute

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